(56 days)
Use of Fluconazole 25μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of pathogens to Fluconazole. The concentration of 25 ug has been shown to be active in vitro against most strains of Candida species listed below, as described in the FDA approved drug insert for this agent.
Active In Vitro and in Clinical Infections Against:
Candida albicans Candida glabrata (Many strains are intermediately susceptible) Candida parapsilosis Candida tropicalis
Active In Vitro Against:
Candida dubliniensis Candida guilliermondii Canaida kefvi Candida lusitaniae
Fluconazole 25μg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately Fluconazole 25pg BBB - SchsFDBS - 15 prepared of the drug manufacturer. Each Fluconazole disk is clearly decellinied aniounts of I noomazone supplied of content. Fluconazole cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box. or in a package comaining minoregnated uisks that are packed as entrely surettings in virro susceptibility evaluations by the agar diffusion test method.
Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate of minimize variability in the testing. Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.
The provided 510(k) submission describes an antimicrobial susceptibility test disk for Fluconazole and provides a high-level overview of the device and its intended use. However, it does not contain the detailed study data, acceptance criteria, or performance metrics typically found in a clinical study report or a more comprehensive summary of scientific data.
Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results directly from the provided text.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification, and predicate device.
- Intended Use: For semi-quantitative in vitro susceptibility testing of Fluconazole against various Candida species.
- Device Description: How the disks are prepared, the concentration of Fluconazole, and the historical context of agar diffusion methods.
- Device Principle: How the zone of inhibition is measured and interpreted against approved pharmaceutical package inserts.
- Device Comparison: Similarities and differences to a predicate Ciprofloxacin disk.
- Substantial Equivalence Testing Data: This section references the "Fluconazole drug package insert, 'Susceptibility Testing Methods: Diffusion Techniques' (Appendix 1)" for the data. This Appendix 1 is crucial for your request but is not included in the provided text.
To answer your questions, I would need to review the "Fluconazole drug package insert" and its "Susceptibility Testing Methods: Diffusion Techniques" section (Appendix 1) which is referenced but not provided.
Based only on the provided text, I can infer the following about the study context, but not the specific data:
- Type of Study: The device relies on "standardized agar diffusion test procedures" and "zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 19-949." This indicates that the "study" for establishing the zone size interpretations was part of the original drug's NDA approval process, and this 510(k) is demonstrating the equivalence of the disk itself to that established methodology.
- Ground Truth: The ground truth for interpreting the zone sizes would have been established during the drug's NDA approval. It would typically involve correlation of in vitro MIC (Minimum Inhibitory Concentration) values with clinical outcomes data. The document mentions "comparing zone diameters to those found in the approved pharmaceutical package insert," which implies the established breakpoints (zone diameter cutoffs for Susceptible, Intermediate, Resistant) from the NDA.
- No information is available regarding:
- Specific acceptance criteria for the disk device itself (beyond meeting the established zone size interpretations from the drug's NDA).
- Reported device performance (e.g., categorical agreement, essential agreement).
- Sample size used for the test set.
- Data provenance for the test set.
- Number of experts or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone performance.
- Sample size for the training set (if applicable for a traditional ML/AI device, which this is not).
- How ground truth for a training set was established.
To reiterate, the substance of your request is contained within the "Fluconazole drug package insert, 'Susceptibility Testing Methods: Diffusion Techniques' (Appendix 1)" which is implicitly part of the submission but not provided in the input text.
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).